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| Name | Class |
|---|---|
| Ligue contre le cancer, France | OTHER |
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This is an interventional, prospective, single-center study designed to collect and describe genetic, environmental and psychosocial control data from male participants. The participants did not have any prior history of cancer at the time of the oncogenetic consultation and do not have the family mutation researched during the oncogenetic consultation (targeted genetic testing). The participants are referenced in the IUCT-O medical records as family members of patients suffering from male breast cancer.
The study will be conducted on a population of 120 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | The participants enrolled in this study (MATADOR2) will serve as control group for the patients enrolled in the previous study (MATADOR = MATADOR1) in order to identify:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire completion | Other | In order to meet the study's objective, after written informed consent was obtained, participants will be asked to complete a questionnaire characterizing their environmental and psychosocial context. The questionnaire is to be filled out by the participants at home. It is estimated that the questionnaire will take around 30 minutes to complete. Demographics data will also be collected from the medical records of included participants. |
| Measure | Description | Time Frame |
|---|---|---|
| The environmental and psychosocial data in the questionnaire will be described by the usual descriptive statistics. | A 75-question questionnaire (created for the purposes of the MATADOR project) will cover such aspects as the participant's living conditions, professional situation, qualifications or level of education, social environment, early life and family environment, general health and recent significant events. For each question of the questionnaire: quantitative variables will be described by the median, minimum, maximum and number of missing data, and qualitative variables by the numbers, percentages and number of missing data. | 30 days approximately for each participant, 1 year and 1 month in total for all patients |
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| Measure | Description | Time Frame |
|---|---|---|
| The list of genetic variants of the participants will be otained through a WES (Whole Exome Sequencing) analysis | Through study completion, an average of 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayman AL SAATI, PharmD, PhD | Contact | 0033 5 31 15 52 42 | alsaati.ayman@iuct-oncopole.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire du Cancer Toulouse - Oncopole, Laboratoire d'oncogénétique | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D018567 | Breast Neoplasms, Male |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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This study is intended to serve as a control group for the MATADOR study (=MATADOR1) which was conducted on patients presenting with male breast cancer (MBC). Their environmental and psychosocial background was studied through the completion of a questionnaire.
In this study (MATADOR2), the participants were free of cancer at the time of the oncogentic consultation and did not present the family mutation (on the MBC predisposition genes routinely tested in oncogenetic consultation).
In this control group, the participants will complete the same questionnaire as the MATADOR1 patients. In addition, the genetic predisposition factors will be analyzed through genetic analysis (Whole Exome Sequencing).
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| Genetic analysis (WES) | Other | In order to meet the study's objective, after completion of the questionnaire, a genetic analysis (Whole Exome Sequencing) will be conducted on an archived blood sample collected during the initial oncogenetics consultation. The patient had given consent to this sample in order for the oncogenetics laboratory to perform the targeted genetic analysis (presence of family mutation). No additional blood sample will be collected for the purpose of this study. |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |